Healthy Skepticism Library item: 14980

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Armstrong D.
Medicare Shift on 'Off-Label' Drugs Raises Issue of Conflicts
The Wall Street Journal 2009 Jan 27
http://online.wsj.com/article/SB123302745342318667.html

Full text:

A rule change by Medicare, expected to expand patient access to cancer drugs, has sparked questions about rising health-care costs and the influence of drug makers.

The move will make Medicare coverage automatic for a wider array of “off-label” uses of the drugs — that is, uses not specifically approved by the Food and Drug Administration. A number of cancer doctors and drug companies urged the agency to take the step, arguing that patients needed more help paying for expensive treatments when other aren’t working.

But critics say that drug guides that will now decide coverage aren’t always supported by research and could be influenced by their ties to the companies that make drugs.

In November, Medicare expanded to four, from one, the number of guides that can be used to authorize coverage for a drug’s use on a particular form of cancer. A judgment by any one of the guides that a drug is effective is sufficient for coverage, and the new guides deem more drugs effective for more cancers than the old guide did.

Medicare spends more than $3 billion a year on cancer drugs — and private insurers, who pick up most of the rest of the $45 billion spent on cancer drugs, typically follow Medicare’s coverage guidance.

In the old system, oncologists argued that the single guide, published by the American Hospital Formulary System, was slow to recognize new studies of off-label uses.

A 2007 study indicated coverage could now be greatly expanded. The study, by researchers at Tufts and Duke universities looked at 14 off-label uses of six cancer drugs, including big sellers Avastin from Genentech Inc. and Gemzar from Eli Lilly & Co. Only two of those uses were supported in the guide used in the old system — but all 14 off-label uses can be found in at least one of the four volumes.

Thomas Kaye, the pharmacy director at a Kentucky insurance plan that processes claims for Medicare, said he expects payments for cancer drugs to rise under the new system. Mr. Kaye said the new system is “biased toward the compendia and influence from drug makers.” He and others note that two of the compendia are funded, in part, by pharmaceutical concerns and a third uses reviewers with financial relationships to drug makers.

Frances Visco, president of the National Breast Cancer Coalition, a patient-advocacy group, said an independent government panel should decide coverage. “A lot of these decisions are being made by associations with conflicts….In cancer so many of the therapies are not that effective but can be very expensive.”

One of he four designated guides, published by the National Comprehensive Cancer Network, a group of hospitals, relies on panels of experts to review drugs — half of whom, according to the NCCN Web site, had financial ties with a cancer drug maker. The NCCN says it limits the potential for industry bias by disclosing the conflicts and making sure panels are large enough to prevent undue influence by a single voice.

NCCN also received $230,000 in funding last year from a number of big drug makers. One company listed on the NCCN Web site as a financial supporter, the ImClone unit of Eli Lilly, also wrote a letter to Medicare officials urging them to add the NCCN compendium to its list of recognized drug guides. ImClone is the maker of the cancer drug Erbitux. The NCCN in September added new off-label indications for Erbitux to its compendium.

ImClone said it “only promotes the use of Erbitux for on-label, FDA-approved indications” and “it is not our practice to comment on compendia listings.”

The Tufts and Duke researchers, in their 2007 study, said that listing decisions by another of the recently added guides, Drugdex, often had little support in the medical literature. Drugdex is owned by publisher Thomson Reuters Corp.